Thermally controlled shipping systems are used to transport a variety of temperature sensitive products and goods including, for example, biological products, pharmaceuticals, perishable foodstuffs, and other high-value materials that require controlled temperatures, varying from below freezing to room temperature. The thermal objective for such a system is to maintain a predetermined temperature range in order to protect the payload, i.e., the article(s) being shipped, from experiencing harmful external environmental temperature fluctuations. Typical thermally controlled shipping systems are designed to insulate the payload and maintain a predetermined temperature, whether cooler or warmer relative to ambient temperatures.
Biological products such as blood, biopharmaceuticals, reagents, and vaccines with required storage refrigeration conditions are commonly transported using thermally controlled shipping systems. Because of these products' susceptibility to the external environmental temperature, increased regulatory scrutiny of product transport conditions has been implemented to ensure the viability of the payload being shipped. Accordingly, shippers have had to make costly upgrades to their shipping systems and procedures to ensure compliance.
It is thus common practice to employ Temperature Control Management Chain (TCMC) shipment systems and methods to ensure product integrity and regulatory compliance during transportation. A TCMC is a temperature-controlled supply chain. An unbroken TCMC is an uninterrupted series of storage and distribution activities which maintain a given temperature range or prevent exceeding some temperature limit. Such TCMCs are common in the food and pharmaceutical industries, and also for some chemical shipments. One common temperature range for a TCMC in pharmaceutical industries is 2 to 8° C. Frozen (less than −15° C.) and controlled room temperature (15° C. to 30° C.) are also common temperature target ranges. However, the specific temperature (and time at temperature) tolerances depend on the actual product being shipped.
For example, with regard to vaccines, traditionally, all historical stability data developed for vaccines was based on the temperature range of 2-8° C. With recent development of biological products by former vaccine developers, biologics have fallen into the same category of storage at 2-8° C., due to the nature of the products and the lack of testing for these products at wider storage conditions.
The TCMC distribution process is an extension of the Current Good Manufacturing Practices (cGMP) environment to which all drugs and biological products must adhere, as enforced by the U.S. Food and Drug Administration (FDA) or comparable authorities outside the United States. As such, the distribution process must be validated to ensure that there is no negative impact to the safety, efficacy, or quality of the drug substance. The cGMP environment begins with all things that are used to manufacture a drug substance, and it does not end until that drug substance is administered to a patient. Therefore, all processes that might impact the safety, efficacy, or quality of the drug substance must be validated, including storage and distribution of the ingredients and the drug substance.
Maintaining the TCMC can become particularly difficult in the distribution cycle before the end user receives the product. In order to meet this market need, insulated containers using specialty phase change materials (PCM) may be employed that can maintain the temperature of the product during transport and refrigerated storage.
In the past, various “off-the-shelf” container solutions, including those using PCM-based technologies, have been developed, usually for specific payloads. The current time-to-market for developing custom solutions not available “off-the-shelf” is lengthy, and is therefore undesirable by many customers, especially in the clinical trials, diagnostics, and research markets. As such, existing “off-the-shelf” solutions only satisfy a small portion of the market. In particular, existing “off-the-shelf” solutions offer no or very limited variability with regard to the available temperature ranges, time at temperature, and payload size.
Furthermore, there have been other regulatory trends in the art which have challenged the performance of thermally controlled packaging. Most existing thermally controlled systems employ small, parceled-sized packages. Although delivery companies generally do well at ensuring that the package arrives on time, they typically do not ensure that the package is transported in a particular orientation, even if specifically marked on the package. The FDA and other similar regulatory agencies recently have been made aware that most packaging is only designed to perform when shipped “upright” relative to the orientation of the payload. Consequently, enforcement of a requirement that a package work in any orientation is anticipated in the near future. For this reason, it is highly desirable for a thermally controlled package to perform equivalently regardless of its orientation while in transit.
Thus, what is needed in the art is a cold-chain container solution that reduces the need for custom container designs while still permitting a variety of different temperature range requirements to be met. What is further needed is for such a solution to perform consistently regardless of orientation during shipping.